Received Oct 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | — |
Suspected vaccination failure; was diagnosed two weeks later with RSV; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of RSV vaccine. On an unknown date, 2 weeks after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: was diagnosed two weeks later with RSV). The outcome of the vaccination failure was not reported and the outcome of the respiratory syncytial virus infection was unknown. It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to RSV vaccine. The company considered the vaccination failure and respiratory syncytial virus infection to be unrelated to RSV vaccine. Additional Information: GSK receipt date:21-OCT-2025 This case was reported by a patient via interactive digital media. Consumer reported that got the vaccine a couple years ago and was diagnosed two weeks later with Respiratory syncytial virus infection. This case was considered as suspected vaccination failure as details regarding laboratory test confirming Respiratory syncytial virus infection were unknown at the time of reporting. The batch number was not provided, and we are unable to contact the reporter.; Sender's Comments: A case of Vaccination failure, 2 weeks after receiving 1st dose of RSV vaccine, in an adult female patient. Based on the available information a possible causality that the events were caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received